Improving Outcomes for Orphaned Youth: Implementation of Trauma-focused CBT The primary goal of this R01 proposal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). The mental health gap in low and middle income countries (LAMICs) is substantial, with few individuals in need of treatment receiving even basic care. Orphaned children and adolescents currently number 143 million worldwide, with nearly 50 million in Sub-Saharan Africa alone, 16.6 million due to HIV/AIDS. These are vulnerable children, who often have mental health problems subsequent to parental death as well as high rates of trauma exposure. In our feasibility study of TF-CBT with orphans in Tanzania, we have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts. Building on this initial study, we propose a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study extends our prior work in three ways: 1) includes a comparison condition; 2) includes two countries to examine broader applicability and effectiveness; and 3) involves partnering with the experienced lay counselors from the feasibility study to train and supervise lay counselors, in an attempt to build local responsibility and take steps toward sustainability. The proposed study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with our US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, we will train nine counselors in each country, who deliver 20 groups in each site (10 rural, 10 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from our team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ ad KE counselors, and these local trainers provide the TF- CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. We expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in LAMICs. Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap. PUBLIC HEALTH RELEVANCE: The primary goal of this R01 proposal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) for treating unresolved grief and traumatic stress for orphaned children and adolescents in two East African countries, Tanzania and Kenya. The mental health gap is substantial, with few individuals in need of treatment receiving even minimal supports. Among those in need, orphaned children and adolescents, who currently number 143 million worldwide, with nearly 50 million in Sub-Saharan Africa alone, often have mental health problems subsequent to parental loss.